TalentBurst | Sr Quality Engineer CA | irvine, ca

24 hours ago


Irvine CA United States TalentBurst Full time

Position: Sr Quality Engineer (CAPA) , Req#: 9230-1
Location: Irvine, CA (this is a hybrid/flex position, Pacific Coast time zone.)
Duration: 12+ Months Contract

Job Description:

What does your group do? Manage the CAPA process to ensure all CAPAs are closed on time and documentation is on compliance with the regulations and standards procedures.

Does your team use any specific technology/software you want us to look out for? EQMS, Ignite, and JDE.

Do you foresee this role being needed again ? Yes, as the Irvine CAPA teams now is also responsible for managing international CAPAs.

What will a typical workday look like? The candidate will work 8 hours a day (1st shift) and will be interacting with other team members, stakeholders, etc.

What will the work schedule be? Can any overtime be expected? From 8:00AM to 5:00PM. Yes, there are days that we probably will need to work more than 8 hours, it depends on the timeline of the CAPAs, projects, etc.

Will there be any travel involved? No travel involved. Only to campus, if needed

Will you consider remote work? If yes, will they need to be in a specific time zone? Yes, this is a hybrid/flex position, Pacific Coast time zone.

What are your top 3 required technical skills? Must haves? Engineering degree, CAPA experience, Root Cause Analysis experience, technical skills, team player, independent, quality experience.

What are nice to have skills? Project Management

Education and Experience:

  • Bachelor's degree in engineering required.
  • 5-7 years of experience required.
  • Medical device experience
#TB_EN

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